Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Reported: August 31, 2016 Initiated: July 21, 2016 #Z-2600-2016
Product Description
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Reason for Recall
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 120 units from multiple lots
- Distribution
- US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.. Recalled by Integra LifeSciences Corp.. Units affected: 120 units from multiple lots.
Why was this product recalled? ▼
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2600-2016.
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